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FDA OKs RevMeds Promising Pancreatic Cancer Drug

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FDA approves Revolution Medicines Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer.

Comments on Expedited IND Pilot

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Three stakeholders provide their responses to an FDA Request for Information on the Operation TrialBlazer Expedited IND Pilot Proj...

Device, Drug Recalls Down, Units Up

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The Sedgwick Recall Index shows that in the first half of 2026, medical device and drug recalls fell, but the number of recalled u...

Jemperli sBLA for Rectal Cancer Accepted for Priority Review

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FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated S...

Wearable Device Monitors Ketone Levels and Blood Sugar

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FDA grants Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System ...

Group Backs Circulating Tumor DNA as Early Endpoint

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Friends of Cancer Research publishes two scientific articles it says demonstrate the value of circulating tumor DNA as an early en...

R3 Selling Unapproved Drugs, Biologics, FDA Says

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FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that...

FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

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FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pedia...

Create Unified Reference-Anchored Framework for Follow-Ons

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Washington State University pharmacy professor Sarfaraz Niazi asks FDA to create an equivalence framework for follow-on human drug...

Webinar on FDAs Bayesian Draft Guidance

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FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologic...